Regulatory Affairs
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Education and Experience:
  • Bachelor's Degree in Pharmacy or Life Science
  • 2-3 years regulatory experience, or combination of higher education/less experience
  • Or substitution of equivalent relevant work experience
Knowledge, Skills and Abilities:
  • Broad regulatory affairs experience
  • Good interpersonal skills
  • Good knowledge Global Regulatory Affairs Procedures
  • Proven ability to work effectively in a team
  • A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
  • Familiar with computers and their applications
  • Good organizational and planning skills
  • Must be able to work autonomously with minimal supervision
  • Planning skills
  • Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking